Jim Vaught: Let's start with some background about how the new edition of the ISBER Best Practices was developed and some of the highlights of the process and the changes featured.
Lori Campbell: There are two new sections in this version of the Best Practices. One covers cost management, which provides guidance on assessing costs during the development of a repository and analyzing the ongoing costs associated with the maintenance and operation of the repository. The other new section we added was “Specimen Access, Utilization, and Destruction,” and it addresses issues on data sharing, such as the proper transfer of specimen-specific and donor-specific data and security concerns for the distribution of data.
Also, we expanded on many of the sections. Some of the largest expansions featured organizational requirements of a repository. We changed the title of that section to “Repository Planning Considerations” and some of the topics added include repository development, which covers different repository models, organizational considerations, determining specimens to be collected and services to be provided. It includes funding and financial considerations and outsourcing services. We also expanded the facilities section, really to include guidance on relocation of a repository, which was the largest change in that section.
These are just a few highlights of the changes and updates incorporated in this version.
Jim Vaught: Were there any changes that you felt were critical to this new edition?
Lori Campbell: This edition includes references within the document itself. Where we could incorporate references to make it more evidence-based, we did that. Best practices are not truly evidence-based practices; however, by adding references where they fit, it allows the document to be more reference-based and evidence-based and therefore a better tool for users.
Amy Skubitz: Also this version has a more international flavor to it and it looks at other types of specimens rather than just human specimens. We made a real effort to draw in more ISBER members who had that expertise so that it incorporates more international material rather than just United States-centric and not just human specimens. Now we have more animal collection information and other types of biospecimens than before.
Jim Vaught: Who is the target audience for the
Best Practices
and what are some ways the practices should be implemented? Are there a variety of ways that they should be implemented depending on what sort of collections you have?
Katherine Sexton: I think it is important to point out in the beginning of our discussion that the Introduction to the Best Practices states that the term “best practice” is used in cases where a level of operation is indicated that is above the basic recommended practice or more specifically designates the most effective practice. And the Introduction also recognizes that certain locations or repositories with particular financial constraints may not be able to adhere to each of the items that are designated as the best practice. So repositories that define themselves in those categories will need to determine how to best adhere or which ones apply to them and which ones do not.
Regarding the target audience, I think anyone collecting specimens for use in research that is interested in making sure their collection, their processing, their storage, their distribution procedures are as good and high-quality as possible—that is who our target audience is. This could range from an investigator with one freezer in his lab to commercial enterprises with hundreds of freezers. I think we would be in agreement that a huge range could benefit from the Best Practices.
Fay Betsou: We imagine that through the Best Practices people will identify procedures which they have not yet thought of or implemented, so that they can start implementing them, reviewing their standard operating procedures by adding new elements, and writing new standard operating procedures based on the Best Practices.
Katherine Sexton: I would also add that at the Biorepository Research Network meeting (Feb. 2012), I was very encouraged to see there was a presentation about a recently launched U.S./Latin American network that utilized the ISBER Best Practices to help set up their network in Latin America. I thought that was pretty significant.
Amy Skubitz: I think that the ISBER Best Practices are really being looked at by a lot of people who are starting repositories. And, every year, here at the University of Minnesota, we have a short course on biopreservation techniques. And, literally, these people who are starting new banks, they have so many questions and the first thing that we give them is the ISBER Best Practices. It is just a great tool, because you can just look in the Table of Contents and it pretty much covers every issue that they have questions about. It is a great starting place for repositories.
Rebecca Pugh: I agree and here at the National Institute of Standards and Technology we have had several collaborations with environmental specimen banks around the world, specifically in Korea and France, where representatives have come to our facility to learn our standard operating procedures on how we handle projects for environmental specimen banking. But, first and foremost, when they are trying to design their specimen bank, I show them the ISBER Best Practices and say, “This is how you set up a general biorepository and this is all the information you need for that.”
Jim Vaught: Does ISBER assess where and how the
Best Practices
are implemented?
Lori Campbell: The ISBER self-assessment tool is available for this purpose.
Fay Betsou: Yes, the self-assessment tool can also help people identify where to start the implementation. It identifies the areas of the highest risk in one's repository operations, so, instead of being more or less lost—the Best Practices is a large document—using the self-assessment tool can help identify where to start.
Katherine Sexton: The self-assessment tool for the Best Practices is probably the main thing we have done regarding implementation. We have not queried the ISBER membership about how they have used the Best Practices, although we do hear things through meeting presentations and so forth. So that is something that we could certainly think about further in the future.
Jim Vaught: How can you apply the
Best Practices
to both large- and small-scale repositories? Should there be tiered levels? What are some of the cost-benefit issues related to implementing best practices?
Katherine Sexton: We actually did have a discussion at one point about trying to do tiered levels; however, we backed off of that because people would not necessarily fall into those tiers. For instance, there could be small repositories that might be well-funded and have the resources to implement and then other small ones that would not. And so we could not really define where those tiers would necessarily be. So we decided to instead just make it very clear that the Best Practices represented the ultimate standard of what everyone should strive for, but recognizing that not everyone would be able to get there. Nor would every section or discussion in the Best Practices necessarily apply to every repository, because repositories are very different in their goals, in their mandates, and in the types of specimens they collect.
Fay Betsou: Also the way in which each repository may apply the Best Practices is not necessarily the same. For example, if you look at a best practice such as the document control system, the way in which everyone is going to implement it may be different, but what is important is that there is a document control system.
Amy Skubitz: Right. Another example may be how you lock your doors. You can get into the discussion, “Should there be keys? Or should you have a keypad? Or should you have retinal scanning?” And some places can afford certain things and some places cannot, but the idea is you want to have it locked. So the overall goal is the same. It is just “How are you going to implement it?”
Lori Campbell: Also some of the Best Practices can be used to convince your parent organization or institution into implementing some changes. A lot of places are like mine where, for instance, I do not control how the security is done; but if I can go to the Centers for Disease Control and Prevention with the Best Practices and say, “This is what needs to be done,” it gives me some information and evidence to work from.
Jim Vaught: Are there any particular items featured that people have told you all are really budget-busters, such as 24-hour alarms or developing a comprehensive quality-management system and other IT issues?
Katherine Sexton: Yes, all of the above! But, Jim, you used the example of informatics. For a very small startup repository, the goal is to be able to track information and so, if they cannot afford a robust informatic system initially, they should not have to necessarily worry about that until such time as they can afford one and have enough experience to at least know what it is they need to track.
Debra Garcia: The important thing is to make sure everything is documented and that they have a system to track information, and that could initially be some simple informatic system, if it meets their needs.
Amy Skubitz: Other issues were really in the facilities—what people could afford or what they had access to. Things like power generators, security systems, and even the heating, ventilation and air conditioning system; a lot of facilities do not have the authority to change what is already at their site.
Katherine Sexton: I would add practicality to that list. What comes to mind is our discussion about having a backup freezer sitting at the ready when there is a failure. In an ideal world, that would be wonderful, but the practicality is that there are many repositories that cannot afford to do that.
Fay Betsou: What we want readers to do is to think about the situation, “What would I do if that happened?” and to have a plan in place that they could implement, which might include identifying other space in another lab that they could call on in an emergency situation.
Jim Vaught: Having the
Best Practices
be evidence-based is something we discussed earlier. A point in regards to this is what if the ISBER
Best Practices
, or any best practices, for that matter, become part of some accreditation or certification program in the future, then you would want as many of the best practices as possible to be evidence-based.
And so I know that we all deal with this, to a certain extent, but what do you think about whether recommendations are sufficiently evidence-based and, as we see in our biospecimen research database, there are all kinds of conflicting evidence in the literature, so how do you decide when you have reached a threshold where the evidence is strong enough that that becomes an evidence-based practice? And then how do you monitor and update those practices over time?
Katherine Sexton: Again, I would refer to the Biorepository Research Network meeting many of us recently attended. Those of us who have been attending these kinds of meetings know that we are still struggling to have evidence-based biorepository science. And there are a lot of things that we do not know and we have not determined or there is conflicting evidence.
However there are also a lot of things that, because of our experience, we know are the best of all possible options. And so we did struggle with that and tried to use evidence-based practices as much as we could and use the corporate knowledge of the experienced ISBER community to bring together what we felt was the best in each of the discussions in the document. I think, particularly with this version, where there had been some evidence-based conclusions, we tried to incorporate those and improve and add to those sections.
Amy Skubitz: Also, after the third edition was written it was sent out to the members to read and there were very few comments returned where people said, “That is not true at all” and pointed to a reference to something that proved what was written in the third edition was scientifically incorrect.
So I do think that, maybe in the fourth edition, we could look forward to putting in more references and especially evidence-based references, which would help the document as a whole.
Lori Campbell: There were many instances where something would come up and there was still some question about the topic. Though, because our field is very small and generally the experts know each other, there was a lot of crosstalk among experts. They were already e-mailing each other and then getting back to us and saying, “I have sent this to so-and-so who agrees or disagrees or we have come to a consensus.” So it just happened organically; it was never a contentious issue. It was a very successful process, as far as getting a consensus among the industry.
Debra Garcia: Also, as new technologies arise, we are going to see some of what we consider to be evidence-based start to change. There is going to be new evidence that practices can be done in different ways. I think our Best Practices is the starting point so that we can build off of it.
Jim Vaught: Building on the comment about changes in technology, one of the things that we have had to do at NCI over the years is evaluate different storage technologies, because, as we all know, freezers are very expensive to maintain. So, when possible, we have tried to shift some storage into alternate types of media; drive storage media and the Biomatrica and GenVault technologies as well, just to save space and money.
But, in order to do that, you have to have evidence that you are getting the same quality of sample, nucleic acids or whatever, out of those alternate technologies. And so that becomes an evidence-based process that you have to go through when you change your technology.
Jim Vaught: There are other best practice guidelines available in the field: what is the relationship between ISBER
Best Practices
and the others—what are some similarities and differences?
Katherine Sexton: At least to my knowledge, the ISBER Best Practices are the most comprehensive, as far as what they attempt to address. The NCI Best Practices, for example, are excellent, but they target a certain audience. And I think the ISBER Best Practices strives to meet the needs of the ISBER audience, which is international and which incorporates repositories other than human. I guess the main difference from these and most other best practices are that they have perhaps a more limited target audience.
Fay Betsou: There are normative (certification standards) documents that contain general requirements. They tell people what they should have in place, but they do not tell people how exactly they should implement it. The ISBER Best Practices is a document that lists not only the management and technical requirements, but tells how to fulfill them. The Best Practices is not a norm/standard, but can be considered as an assistance document that advantageously complements and explains future and/or existing repository certification standards.
